Rapid diagnosis of preeclampsia at the point-of-care

Project Information

PEDPOC

Grant agreement ID: 848551

DOI

10.3030/848551

Project closed

EC signature date 17 April 2019

Start date 1 May 2019

End date 31 October 2020

Funded under

• EXCELLENT SCIENCE - Future and Emerging Technologies (FET)

Total cost

€ 219 375,00

EU contribution

€ 100 000,00

Coordinated by

MOMM DIAGNOSTICS GMBH
Switzerland

Periodic Reporting for period 1 - PEDPOC (Rapid diagnosis of preeclampsia at the point-of-care)

Reporting period: 2019-05-01 to 2020-10-31

Summary of the context and overall objectives of the project

Preeclampsia (PE) is one of the most common pregnancy complications, affecting 2-8% of all pregnancies worldwide, and causes severe – even fatal – threats to mother and baby. The progressive and unpredictable condition can only be resolved by early delivery.
Early diagnosis of the condition is of utmost importance to minimize complications and to save lives, as measures can be taken to suppress the effects of PE until delivery is safe for the baby. The current standard diagnostic methods - blood pressure and proteinuria measurements - result in a high failure rate to diagnose PE.
MOMM Diagnostics, a spin-off from Empa is developing a fast and precise blood test for preeclampsia, based on a novel biosensor technology. Our rapid diagnostic test will assist doctors on-site. Immediate information during pregnancy check-ups helps to optimize treatment, reduce stress and anxiety for expectant mothers, save lives, and reduce healthcare costs.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The business case for MOMM Diagnostics' preeclampsia test was elaborated by performing market research. Market size and value proposition were addressed by questioning customers (obstetricians and gynecologists). A route to market was defined and is summarized in a business plan.

MOMM and Empa have tested the feasibility of using extended-gate field-effect transistors (EGFET) for the readout of immunoassays. We focused on implementing this technology in a rapid test format. We have successfully demonstrated the application of such sensors in combination with lateral flow immunoassays.

Electrical detection of biomarkers, by integrating EGFET biosensors in single-use cartridges has been developed. An immunoassay for a preeclampsia biomarker was successfully adapted on a lateral flow test format. A wide quantification window in the clinically relevant concentration range has been achieved in spiked serum samples. A fully functioning prototype consisting of an electrical reader and test cartridge with integrated EGFETs will be finished by the end of 2020.

The PEDPOC project allowed MOMM to establish a technical roadmap to develop a market-ready in-vitro diagnostics device. MOMM continues its development and aims to launch its preeclampsia test in 2023.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Preeclampsia is a significant health problem and costs burden (1/3 of obstetric costs; over 2B USD in the US alone). Biochemical tests are currently becoming the new gold standard in PE diagnostics, thanks to a better understanding of the condition. Besides the added value for doctors and patients, recent studies have shown the economic benefits of PE testing in several countries. As of Q3, 2019 PE tests are being reimbursed in Switzerland and Germany, with more countries following this trend.
According to a report published by Fortune Business Insights, the global preeclampsia diagnostics market size was USD 969.5 million in 2018 and is projected to reach USD 2,165.0 million by 2026, exhibiting a CAGR of 10.7% during the forecast period.
MOMM aims to launch its PE test in 2023. Focusing on Europe and the U.S. with 11.6 million births per year, a market share of 5-8% after 5 years of sales results in sales of 60-100 million CHF p.a.

MOMM Diagnostics rapid preeclampsia test